Novartis confirms its leadership in ophthalmology by entering a new therapy area. Acquisition of Encore Vision, Inc. to add first-in-class disease modifying topical treatment for presbyopia patients to the Novartis ophthalmology pipeline in an area of high unmet medical need and high prevalence

Presbyopia is an age-related loss of near distance vision affecting approximately 80% of people over the age of 45; characterized by a progressive inability to focus on objects nearby, making everyday activities such as reading challenging; current therapies only provide optical correction without addressing cause of vision loss

- Novartis announced today that it has entered into a definitive agreement for the acquisition of Encore Vision, Inc., a privately-held company in Fort Worth, Texas, USA, focused on the development of a novel treatment in presbyopia. This acquisition would add a first-in-class disease modifying topical treatment for presbyopia to the Novartis ophthalmology pipeline, providing a potentially disruptive innovation to patients in a new therapeutic area of high unmet need and high prevalence. The transaction is subject to customary closing conditions, including regulatory approval. The financial details of this transaction are not disclosed.

"There is a large need for innovative, effective and safe treatment options for people with presbyopia, and there is currently no disease-modifying treatment available at all," said Vasant Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Novartis confirms its leadership in ophthalmology by entering another new therapy area. The addition of this topical disease modifying treatment to our portfolio, if successful, will provide affected people with a new option to improve and maintain their vision and quality of life."

Encore Vision’s lead investigational product, EV06, is a first-in-class topical treatment for presbyopia. Presbyopia is a common age-related loss of near distance vision characterized by a progressive inability to focus on objects nearby, making everyday activities - such as reading - challenging. It is estimated that more than 80% of adults over the age of 45 develop presbyopia ; currently there are no safe, effective and well-tolerated topical treatments available that could stop progression of or even reverse this condition.

In a phase I/II masked, placebo-controlled proof of concept study, 50 patients were treated daily for 90 days with topical EV06 and 25 patients with placebo. EV06 showed a statistical significant difference to placebo in distant corrected near vision at all time points measured (from day 8); at day 90, 82% of participants treated with EV06 had 20/40 near vision (or 0.30 LogMAR) versus 48% in the placebo group. Near vision of 20/40 allows for majority of near vision tasks in most people.